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Trial registered on ANZCTR


Registration number
ACTRN12621001742864
Ethics application status
Approved
Date submitted
9/11/2021
Date registered
20/12/2021
Date last updated
12/07/2022
Date data sharing statement initially provided
20/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
BeCALM: a pilot randomised controlled trial of an intervention to reduce procedural anxiety during radiotherapy for cancer
Scientific title
Biofeedback Enabled CALM (BeCALM): The effect of biofeedback on anxiety during radiotherapy treatment - a pilot randomised controlled trial
Secondary ID [1] 305755 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BeCALM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
procedural anxiety 324249 0
cancer 324601 0
cancer radiotherapy 324602 0
Condition category
Condition code
Cancer 321745 321745 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the 'BeCALM intervention' group will receive treatment as usual, as well as the intervention.

Radiotherapy (RT) treatment session 1 - Each participant will receive pre-treatment education with a radiation therapist to discuss what to expect during treatment. During the pre-treatment education, the radiation therapist will provide a brief explanation of the biofeedback device (pulse oximeter) and how to use it. The radiation therapist will allow the participant to test the device and will briefly coach the participant on biofeedback techniques. The participant will be taken to the treatment bunker to commence RT. The participant will be provided with the pulse oximeter in the treatment bunker which they will wear for the duration of the treatment session. Sound will be enabled on the device (beep sound reflecting pulse rate), and it will be adjusted to a volume that is comfortable for the participant. Radiation therapists will provide breathing prompts during the treatment session at their discretion (via the speaker). The breathing prompts were designed, based on mindfulness exercises described in Khazan (2019) Biofeedback and Mindfulness in Everyday Life: Practical Solutions for Improving Your Health and Performance

RT treatment session 2 – Each participant will be taken straight from waiting room to the treatment bunker to commence RT. The participant will be provided the pulse oximeter in the treatment bunker which they will wear for the duration of the treatment session. Sound will be enabled on the device (beep sound reflecting pulse rate), and it will be adjusted to a volume that is comfortable for the participant. Radiation therapists will provide breathing prompts during the treatment session at their discretion (via the speaker).

RT treatment sessions generally occur five days a week (week days) for a number of weeks. Therefore, it is likely the first two sessions will occur on consecutive days.
The duration of each session is varied dependent on the type and location of the cancer.

Adherence: Radiation therapists will be required to complete a 'Treatment Observations' form at the end of each participant treatment session to record adherence to the intervention, including: whether the pulse oximeter was worn; whether the sound was on or off; if not, why?; whether breathing prompts were delivered and; if not, why?
Intervention code [1] 322157 0
Treatment: Other
Intervention code [2] 322377 0
Treatment: Devices
Comparator / control treatment
Participants in the 'treatment as usual' group will receive usual care.

Treatment as usual will include:

RT treatment session 1 – Each participant will receive pre-treatment education with a radiation therapist to discuss what to expect during RT. Immediately following education, the participant will be taken to the treatment bunker to commence RT. The participant will be asked to wear the pulse oximeter (for data collection purposes only), with the sound disabled on the device.
RT treatment session 2 – The participant will be taken straight from waiting room to the treatment bunker to commence RT. Participants will be asked to wear the pulse oximeter (for data collection purposes only), with the sound will be disabled on the device.

RT treatment sessions generally occur five days a week (week days) for a number of weeks. Therefore, it is likely the first two sessions will occur on consecutive days.
The duration of each session is varied dependent on the type and location of the cancer.
Control group
Active

Outcomes
Primary outcome [1] 329500 0
Feasibility of the intervention as measured by:

• Percentage of treatment sessions in which the intervention (pulse oximeter and breathing techniques) was successfully delivered (and reasons why not successfully delivered). Radiation therapists will be required to complete a 'Treatment Observations' form at the end of each participant treatment session to record adherence to the intervention, including: whether the pulse oximeter was worn; whether the sound was on or off; if not, why?; whether breathing prompts were delivered and; if not, why?
• Author created feasibility items included in the radiation therapist feasibility and acceptability survey
• Recruitment and retention rates (project records)
Timepoint [1] 329500 0
Treatment 2 Post RT Assessment (immediately post radiotherapy treatment 2)
Primary outcome [2] 329501 0
Acceptability of the intervention (to patients) as measured by:
• Author created acceptability items included in the Post RT participant assessments
Timepoint [2] 329501 0
Treatment 2 Post RT Assessment (immediately post radiotherapy treatment 2)
Primary outcome [3] 329821 0
Acceptability of the intervention (to radiation therapists) as measured by:
• Acceptability item (item 4) included in the radiation therapist feasibility and acceptability survey
Timepoint [3] 329821 0
Radiation therapist feasibility and acceptability survey (which will be completed following the completion of recruitment and participant data collection)
Secondary outcome [1] 402790 0
Potential Effectiveness of the intervention in reducing procedural anxiety during RT:

• Procedural anxiety will be measured using the State subscale of the State-Trait Anxiety Inventory STAI-S, in the waiting room post-treatment, at RT sessions 1 and 2.

Timepoint [1] 402790 0
Treatments 1 and 2 Post RT Assessments (immediately post radiotherapy treatment sessions)
Secondary outcome [2] 403956 0
Potential Effectiveness of the intervention in reducing procedural anxiety during RT:

• The Distress Thermometer will also be used as a measure of procedural anxiety, and it will be administered in the waiting room post-treatment, at RT sessions 1 and 2, together with the STAI-S.
Timepoint [2] 403956 0
Treatments 1 and 2 Post RT Assessments (immediately post radiotherapy treatment sessions)
Secondary outcome [3] 403957 0
Potential Effectiveness of the intervention in reducing procedural anxiety during RT:

• An analysis of treatment times to compare BeCALM treatment times with TAU treatment times (using a stop watch, treatment time will be recorded at time participant enters treatment bunker to time participant exits treatment bunker).
Timepoint [3] 403957 0
TR treatment sessions 1 and 2 (recorded in the 'Treatment Observations' form completed by radiation therapists during treatment sessions)

Eligibility
Key inclusion criteria
• Aged at least 18 years
• Scheduled to undergo RT at the Calvary Mater Newcastle, Department of Radiation Oncology
• Undergoing 2 or more fractions of RT
• Having sufficient comprehension of English to be able to understand and complete the study documents, and the verbal instructions to use a biofeedback device
• Score greater than or equal to 4 on distress thermometer post SIM
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with breast cancer receiving treatment that involves deep inhalation breath hold
• Patients scheduled to undergo less than 2 fractions of RT
• Patients scheduled to undergo RT using Optical Surface Monitoring
• Inability to provide informed consent or complete the eligibility screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Individual randomisation will be via block randomisation (computer generated) to Treatment As Usual (TAU) or BeCALM. The student researcher/research assistants who will complete the randomisation are also responsible for eligibility screening, and will therefore be kept blinded to the block size to ensure that allocation can not be predicted.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be managed in REDCap. Participants will be allocated a unique computer-generated study number. Individual randomisation will be via block randomisation to Treatment As Usual (TAU) or BeCALM. The student researcher/research assistants will be kept blinded to the block size.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A time convenience sample of adult patients with cancer scheduled to undergo RT will be recruited from the department of RT at the Calvary Mater Hospital. Recruitment will continue for a period of approximately three months, depending on recruitment rate. We anticipate recruitment of approximately 57 participants, based on: 10 patients undergoing SIM per day, a minimum of 3 days of recruitment per week, 20% meeting eligibility criteria with an 80% consent rate.

Descriptive statistics on the number of eligible participants, recruitment and retention rate and reasons for dropout will be provided. Descriptive statistics will also be provided on the sociodemographic and health characteristics of participants.

Primary outcomes
Descriptive statistics will be provided on the feasibility and acceptability assessment items.

Secondary outcomes
Differences in the mean STAI-S score from baseline to Post T2 will be analysed using a linear regression. The outcome in the model will be the individuals STAI-S score at T2 using their baseline STAI score as a covariate.

Similarly, differences in the mean DT score from baseline to Post T2 will be analysed using a linear regression. The outcome in the model will be the individuals DT score at T2 using their baseline DT score as a covariate.

Independent samples t-tests will be conducted to compare the difference in the mean treatment time between intervention and control participants at both treatment 1 and treatment 2.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2022
Actual
8/07/2022
Date of last participant enrolment
Anticipated
21/09/2022
Actual
Date of last data collection
Anticipated
5/10/2022
Actual
Sample size
Target
57
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21064 0
Calvary Mater Newcastle - Waratah
Recruitment postcode(s) [1] 35912 0
2298 - Waratah

Funding & Sponsors
Funding source category [1] 310114 0
University
Name [1] 310114 0
University of Newcastle
Country [1] 310114 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive, Callaghan, NSW, 2308
Country
Australia
Secondary sponsor category [1] 311181 0
None
Name [1] 311181 0
Address [1] 311181 0
Country [1] 311181 0
Other collaborator category [1] 282064 0
Hospital
Name [1] 282064 0
Calvary Mater Newcastle
Address [1] 282064 0
Edith &, Platt St, Waratah NSW 2298
Country [1] 282064 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309802 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 309802 0
Ethics committee country [1] 309802 0
Australia
Date submitted for ethics approval [1] 309802 0
31/08/2021
Approval date [1] 309802 0
09/11/2021
Ethics approval number [1] 309802 0
2021/ETH11356

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115442 0
Dr Ben Britton
Address 115442 0
Mental Health Administration Building
Edith &, Platt St, Waratah NSW 2298
Country 115442 0
Australia
Phone 115442 0
+61 2 40353233
Fax 115442 0
Email 115442 0
Ben.Britton@health.nsw.gov.au
Contact person for public queries
Name 115443 0
Erin Forbes
Address 115443 0
University of Newcastle, PO Box 833, Newcastle, NSW, 2300
Country 115443 0
Australia
Phone 115443 0
+61 2 40353233
Fax 115443 0
Email 115443 0
Erin.Forbes@newcastle.edu.au
Contact person for scientific queries
Name 115444 0
Erin Forbes
Address 115444 0
University of Newcastle, PO Box 833, Newcastle, NSW, 2300
Country 115444 0
Australia
Phone 115444 0
+61 2 40353233
Fax 115444 0
Email 115444 0
Erin.Forbes@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To respect participant privacy.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.